A Phase 3 interventional study of Lumateperone in Major Depressive Disorder, sponsored by Intra-Cellular Therapies, Inc.. Completed at 109 sites in 11 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-03.
Sponsored by Intra-Cellular Therapies, Inc. · Phase 3, Interventional, and Treatment
This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.
At the Screening/Baseline Visit (Visit 1/Day 1), which is the same visit as Visit 8/Day 43 of the lead-in study, eligible patients will receive open-label lumateperone 42 mg once daily for approximately 26 weeks. Patients will continue their background ADT from the lead-in study. Patients will be seen for weekly visits through Visit 5/Week 4. Thereafter, visits will occur every two weeks. A Safety Follow-up visit will occur on Visit 17/Day 197, approximately 2 weeks after the last dose of open-label lumateperone 42 mg.
2,741 studies on the registry are indexed under Depressive Disorder, Major; 558 are open to participants now.
This study's enrollment of 812 is above the median of 80 across 2,282 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Intra-Cellular Therapies, Inc. is the lead sponsor of 40 studies on the registry; 12 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 10 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or:
Drug: Lumateperone
Lumateperone 42 mg capsules administered orally, once daily
The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events
An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period.
Time frame: 26 weeks
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Montgomery-Åsberg Depression Rating Scale
The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Time frame: 32 weeks
Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Clinical Global Impression Scale-Severity
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not ta all ill) to 7 (among the most extremely ill patients).
Time frame: 32 weeks
| Milestone | Lumateperone 42 mg |
|---|---|
| Started | 809 |
| Completed | 684 |
| Not completed | 125 |
| Withdrew: Adverse event | 60 |
| Withdrew: Death | 1 |
| Withdrew: Lack of efficacy | 7 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Protocol violation | 8 |
| Withdrew: Withdrawal by subject | 41 |
| Withdrew: Site closure | 2 |
An AE that occurs during the Open-label Treatment Period will be considered a treatment-emergent AE (TEAE) if it was not present before the date of the first dose of open-label lumateperone or was present before the date of the first dose of open-label lumateperone but changed in severity during the Open-label Treatment Period.
| Participants | Lumateperone 42 mg |
|---|---|
| The Number and Percentage of Patients Reporting Treatment Emergent Adverse Events | 548 |
The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
| score on a scale | Lumateperone 42 mg |
|---|---|
| Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Montgomery-Åsberg Depression Rating Scale | -21.7 ± 8.39 |
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not ta all ill) to 7 (among the most extremely ill patients).
| score on a scale | Lumateperone 42 mg |
|---|---|
| Change From Baseline in One of the 6 Week Double-blind Lead-in Studies (NCT04985942 & NCT05061706) to the End of the Open-Label Treatment Period (a Combined Total of up to 32 Weeks) in the Clinical Global Impression Scale-Severity | -2.5 ± 1.19 |
Collected over From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lumateperone 42 mg | 1/809 (0.1%) | 8/809 (1%) | 322/809 (39.8%) |
| Event | Lumateperone 42 mg |
|---|---|
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 2/809 |
| Alcohol PoisoningInjury, poisoning and procedural complications | 1/809 |
| ContusionInjury, poisoning and procedural complications | 1/809 |
| Spinal compression fractureInjury, poisoning and procedural complications | 1/809 |
| Biliary colicHepatobiliary disorders | 1/809 |
| Helicobacter gastritisInfections and infestations | 1/809 |
| Postmenopausal haemorrhageReproductive system and breast disorders | 1/809 |
| Event | Lumateperone 42 mg |
|---|---|
| HeadacheNervous system disorders | 134/809 |
| DizzinessNervous system disorders | 86/809 |
| Dry mouthGastrointestinal disorders | 65/809 |
| NauseaGastrointestinal disorders | 62/809 |
| SomnolenceNervous system disorders | 58/809 |
| DiarrhoeaGastrointestinal disorders | 50/809 |
| NasopharyngitisInfections and infestations | 42/809 |
| Age, Continuous(years) | Lumateperone 42 mg |
|---|---|
| Mean | 46.2 ± 12.22 |
| Sex: Female, Male(Participants) | Lumateperone 42 mg |
|---|---|
| Female | 549 |
| Male | 260 |
| Race/Ethnicity, Customized(Participants) | Lumateperone 42 mg |
|---|---|
| White | 703 |
| Black or African American | 37 |
| Asian | 61 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Multiple | 4 |
| Other | 2 |
| Region of Enrollment(participants) | Lumateperone 42 mg |
|---|---|
| Sweden | 2 |
| Hungary | 15 |
| United States | 225 |
| Czechia | 95 |
| Poland | 147 |
| Slovakia | 32 |
| Bulgaria | 159 |
| Germany | 25 |
| India | 53 |
| Argentina | 56 |
Showing the first 100 of 109 sites across 11 countries.
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Intra-Cellular Therapies, Inc.